This FOA, issued by the Office of Medical Policy (OMP),
Center for Drug Evaluation and Research, Food and Drug Administration,
solicits grant applications from neutral, independent institutions and/or
organizations that propose methods for convening a broad range of
stakeholders, to include those with relevant expertise, and that would support conferences and meetings to explore and address
medical policy issues during drug development, review, and surveillance. In
addition, the awardee would be expected to synthesize, summarize, and
communicate findings from these conferences and meetings to a broad range of
organizations and individuals that have the capability to use the information
to further impact the entire lifecycle of drug development, including the
premarket and post-market settings.

Key Dates

Posted Date

March 17, 2014

Open Date (Earliest Submission Date)

April 5, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

June 1, 2014, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2014

Advisory Council Review

September, 2014

Earliest Start Date

September, 2014

Expiration Date

June 2, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424 (R&R) Application Guide, except
where instructed to do otherwise (in this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all
requirements (both in the Application Guide and the FOA) is required and
strictly enforced. Applicants must read and follow all application instructions
in the Application Guide as well as any program-specific instructions noted in Section IV.
When the program-specific instructions deviate from those in the Application
Guide, follow the program-specific instructions. Applications that do
not comply with these instructions may be delayed or not accepted for review.

The Office of Medical Policy (OMP)
provides CDER oversight and leadership in the development of medical policy,
procedures, and policy initiatives pertaining to drug development, drug
approval, bioresearch monitoring, human subject protection and post market
surveillance processes. When developing and implementing policy, a key step is
often to create a broad public forum with a variety of stakeholders to identify
key issues that will need to be addressed before, during, and after
implementation of any initiative. These discussions can help focus many of the
policy and procedural needs of an evolving initiative. The goal of such
meetings is not to obtain advice relating to regulatory actions or to make
decisions. Nor is the goal to reach a consensus among the participants on any
of the issues discussed. Rather, it is to hear the opinions of experts in the
field and other individual stakeholders.

In addition, it is important to maintain transparency. The
goal of these meetings is to be as inclusive as possible, while still limiting
participation to a number that supports the meetings goals and objectives.
However, it is important to ensure that information from these meetings and
working groups must be described, managed, and made available to the public
using a transparent and open approach.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, FDA scientific or program
staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R)
Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Issuing components intend to commit an estimated
total of $600,000 to fund 1 award.

Award Budget

Application budgets are not limited but need to reflect the
actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

FDA grants policies as
described in the HHS Grants Policy
Statement will apply to the applications
submitted and awards made in response to this FOA.

Applicant organizations must complete and maintain the following
registrations as described in the SF 424 (R&R) Application Guide to be
eligible to apply for or receive an award. All registrations must be completed
prior to the application being submitted. Registration can take 6 weeks or
more, so applicants should begin the registration process as soon as possible. Failure
to complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After
obtaining a DUNS number, applicants can begin both SAM and eRA Commons
registrations. The same DUNS number must be used for all registrations, as well
as on the grant application.

System for Award
Management (SAM) (formerly CCR) – Applicants must complete and maintain an
active registration, which
requires renewal at least annually. The renewal process may
require as much time as the initial registration. SAM registration includes the
assignment of a Commercial and Government Entity (CAGE) Code for domestic
organizations which have not already been assigned a CAGE Code.

eRA
Commons - Applicants must have an active DUNS number and SAM registration
in order to complete the eRA Commons registration. Organizations can register
with the eRA Commons as they are working through their SAM or Grants.gov
registration. eRA Commons requires organizations to identify at least one Signing
Official (SO) and at least one Program Director/Principal Investigator (PD/PI)
account in order to submit an application.

Grants.gov – Applicants must have an active DUNS number and SAM registration in order to
complete the Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for FDA support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

FDA will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the HHS Grants
Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424 (R&R) Application Guide, except
where instructed in this funding opportunity announcement to do otherwise.
Conformance to the requirements in the Application Guide is required and
strictly enforced. Applications that are out of compliance with these
instructions may be delayed or not accepted for review.

All page limitations described in the SF424 Application
Guide and the Table of Page Limits must be followed, with
the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited
to 10 pages.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some components
marked optional in the application package are required for submission of
applications for this FOA. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Research
Strategy: Note that this section will be called “Conference
Plan” in the system-generated Table of Contents.

In the “Conference Plan” section of the application
(uploaded as the Research Strategy attachment), describe the objectives,
specific program, and logistical arrangements for the conference. Describe the
format and list the agenda and speakers, including the principal topics to be
covered, problems to be addressed, and developments or contributions the
conference might stimulate. Provide a detailed justification for the
conference, including the scientific need, timeliness, and usefulness of the
conference to the scientific community.

A critical part of the application for FDA conference
support is the documentation of appropriate representation of women,
racial/ethnic minorities, persons with disabilities, and other individuals who
have been traditionally underrepresented in science in the planning and
implementation of, and participation in, the proposed conference. “Appropriate
representation” means representation based on the availability of these
scientists from these groups known to be working in a particular field of
biomedical or behavioral research. If appropriate representation is not
apparent, no award will be issued until program staff members are assured of
concerted recruitment efforts.

Describe the composition and role of the organizing committee,
and provide the names and credentials of key participants (i.e. speakers,
presenters, session moderators) in the conference, including the basis for
their selection and documentation of their agreement to participate. Estimate
the expected size and composition of the audience, as well as the method of
selection.

Describe plans for publicizing the conference to all
interested participants and for publishing the proceedings (with the latter
plan not being required). Identify related conferences held on the subject
during the past 3 years and how the proposed conference is similar to and/or
different from these, and why it is still necessary and useful. If this is one
in a series of periodic conferences held by a permanent sponsoring
organization, briefly describe and evaluate the last conference in the series.

Applications requesting multiple years of support must
provide the following additional information for each future year requested, in
as much detail as possible:

A. conference topic(s)

B. tentative dates, locations, and participants

C. contingency plans for future conferences dependent upon,
for example, the outcome of the first year’s conference or developments in the
field.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing
Model Organisms, and GWAS Sharing Plan) are expected, but they are not
applicable for this FOA.

Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

Planned Enrollment Report

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report

Not Applicable

Foreign Institutions

Not Applicable

3. Submission Dates and
Times

Part
I. Overview Information contains information about Key Dates. Applicants
are encouraged to submit applications before the due date to ensure they have
time to make any application corrections that might be necessary for successful
submission.

Organizations must submit applications to Grants.gov (the
online portal to find and apply for grants across all Federal agencies).
Applicants must then complete the submission process by tracking the status of
the application in the eRA Commons, an
electronic system for grants administration. eRA and Grants.gov systems check
the application against many of the application instructions upon submission.
Errors must be corrected and a changed/corrected application must be submitted to
Grants.gov on or before the application due date. If a Changed/Corrected
application is submitted after the deadline, the application will be considered
late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the assigned Grants Management Specialist and responsiveness by components
of participating organizations, FDA. Applications that are
incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the FDA Mission all applications submitted to the FDA
in support of biomedical and behavioral research are evaluated for scientific
and technical merit through the FDA Ad Hoc review Process.

FDA is responsible for protecting the public health by
assuring the safety, efficacy and security of human and veterinary drugs, biological
products, medical devices, our nation’s food supply, cosmetics, and products
that emit radiation.

FDA is also responsible for advancing the public health by
helping to speed innovations that make medicines more effective, safer, and
more affordable and by helping the public get the accurate, science-based
information they need to use medicines and foods to maintain and improve their
health. FDA also has responsibility for regulating the manufacturing, marketing
and distribution of tobacco products to protect the public health and to reduce
tobacco use by minors.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

For this particular announcement, note the following:

1. The application should clearly demonstrate an
understanding of the purpose and objectives of

the Cooperative Agreement.

2. The application should clearly describe the steps
involved in a proposed schedule for planning,

implementing, and accomplishing the activities to be carried
out under the Cooperative

Agreement.

3. The application establishes the applicant’s ability to
perform the responsibilities under the

Cooperative Agreement including the availability of
appropriate staff and sufficient

funding.

4. The application should describe the awardee's ability to
act as a neutral, independent third party

to convene a wide group of diverse stakeholders with
relevant expertise related to

5. The application should specify the manner in which
interaction with FDA will be maintained

throughout the lifetime of the project.

6. The application should specify how the awardee will monitor
progress of the work under the

Cooperative Agreement and how progress will be reported to
FDA.

7. The application shall include a detailed budget that
shows: (1) anticipated costs for

personnel, travel, communications and postage, and supplies;
and (2) the sources of

funds to meet those needs, if other than FDA.

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Ad Hoc Review Group(s) convened by the Center for
Drug Evaluation Research in accordance with the FDA Ad Hoc Review process using
the stated review criteria.

As part of the Ad Hoc Review process, all applications:

Will receive a written critique.

Appeals of initial Ad Hoc review will not be
accepted for applications submitted in response to this FOA.

Following Ad Hoc Review, recommended applications will
receive a second level of review by the National Cancer Institute, National
Advisory Board. The following will be considered in making funding decisions:

The technical merit of the proposed project as determined by the
Ad Hoc Review Group.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the Ad Hoc review of the application is completed, the
PD/PI will receive his or her Summary Statement (written critique) via e-mail,
through the Grants Management Specialist.

If the application is under consideration for funding, FDA
will request "just-in-time" information from the applicant as
described in the HHS
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding
Restrictions. Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the NoA
are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs.

The administrative and funding mechanism used for this
program is cooperative agreement, an "assistance" mechanism in which
substantial FDA programmatic involvement with the awardees is anticipated
during the performance of the activities.

Under the cooperative agreement, FDA's purpose is to support
and stimulate the recipients' activities by involvement in and otherwise
working jointly with the award recipients in a partnership role; it is not to
assume direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project, although specific tasks and
activities may be shared among the awardees and FDA as defined below.

a. All awardees are required to participate in a cooperative
manner with FDA.

b. Awardees will retain custody of and have primary rights
to the data and software developed under these awards, subject to Government
rights of access consistent with current DHHS, PHS, and FDA polices.

c. An agency program official or a Center program director
will be responsible for the normal scientific and programmatic stewardship of
the award and will be named in the award notice. FDA staffs have substantial
programmatic involvement that is above and beyond the normal stewardship role
in awards as described below.

Principal Investigator(s) (PI)/Program Director (PD)
responsibility

The Principal Investigator (PI)/Program Director (PD) will
have responsibility for the scientific, technical, and programmatic aspects of
the grant and for day-to-day management of the project or program. The
PD/PI(s) will maintain general oversight for ensuring compliance with the
financial and administrative aspects of the award, as well as ensuring that all
staff has sufficient clearance and/or background checks to work on this project
or program. This individual will work closely with designated officials within
the recipient organization to prepare justifications; appropriately acknowledge
Federal support in publications, announcements, news programs, and other media;
and ensure compliance with other Federal and organizational requirements.

The awardee is responsible for submitting interim progress
reports (e.g. at specified intervals), when requested, to the FDA Project
Officer (PO) and the Grants Management Specialist (listed as contacts on the
Notice of Grant Award) including summary data on progress and expenses to date.

The awardee is encouraged to publish and publicly release
and disseminate results, data and other products of the cooperative agreement,
concordant with the governance and the approved plan for making data and
materials available to the scientific community and FDA. Awardee will work
with the appropriate FDA staff to develop and implement an appropriate rapid
data release policy.

Manuscripts shall be submitted to FDA Project Officer within
two weeks of submission for publication. Publications or oral presentations of
work performed under this Cooperative Agreement will require appropriate
acknowledgement of FDA support. Timely publication of major findings is
encouraged

The awardee is responsible for obtaining approval for the
development and design of FDA projects prior to execution.

FDA Project Officer Responsibility

An FDA Project Officer (PO) with scientific/technical
expertise and other members of the FDA staff will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below:

The responsibilities of the PO include involvement during
conduct of the activity, through technical assistance, advice, coordination,
and/or other assistance activities.

As appropriate, the PO will participate in the definition of
objectives and approaches, and in planning, conducting, and publishing
resulting work from activities under this cooperative agreement. However, the
dominant role and prime responsibility for the activity reside with the
awardees(s) for the project.

The PO will be responsible for the administration and
general programmatic stewardship of the award and have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below:

The FDA through the PO will have access to data generated
under this Cooperative Agreement and may periodically review the data and
progress reports. The FDA PO may use information obtained from the data for
the preparation of internal reports on the activities of the cooperative
agreement. However, awardees will retain custody of and have primary rights to
all data developed under these awards or as stated in the terms and conditions
of award.

Retain the right to have prior approval on the appointment
of all key personnel substantially supported by the grant.

Be directly involved in the guidance and development of the
program and the collaborative structure of for the program.

Participate with the grantee in determining and carrying out
the approaches to be used. Collaboration will also include identifying topics,
agendas, participants, and dissemination of findings and where appropriate,
co-authorship of publications.

Arrange to have professional scientific and
administrative/clerical personnel working in collaboration with the grantee as
required.

Collaborative Responsibilities

As relevant, the PD/PIs in collaboration with PO will work
collaboratively in evaluating the most appropriate methods, publication and
dissemination of findings. Projects require FDA approval prior to
implementation/initiation.

During performance of the award, the PO, with assistance
from other program staff, designated based on their relevant expertise, may
provide appropriate assistance, advice and guidance. The role of the PO will
be to facilitate and not to direct the activities. It is anticipated that
decisions in all activities will be reached by consensus between the PD/PI and
the PO and that the FDA programmatic staff will be given the opportunity to
offer input into this process. The PO will facilitate liaison activity for
partnerships, and provide assistance with access to FDA supported resources and
services.

The FDA will work collaboratively to identify and coordinate
training, professional development and training-related scientific exchange
opportunities.

Dispute Resolution Process

Any disagreements that may arise in technical or
programmatic matters (within the scope of the award) between award recipients
and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the FDA staff, one recipient designee, and a third designee with
expertise in the relevant area that is chosen by the other two; in the case of
individual disagreement, the first member may be chosen by the individual
awardee. This special dispute resolution procedure does not alter the awardees’
right to appeal an adverse action that is otherwise appealable in accordance
with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part
16.Disallowance of Cost.

Copyright

Except as provided in the conditions of the award, when a
publication or similar copyrightable material is developed from work supported
by HHS, the author is free to arrange for copyright without approval of the
FDA. Such copyrighted materials are subject to a royalty-free, nonexclusive,
and irrevocable license to the Federal government to reproduce them, translate
them, publish them, and use and dispose of them, and to authorize others to do
so for Federal government purposes.

3. Reporting

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in
the HHS Grants
Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the HHS Grants Policy
Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable FDA grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.